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    3 Committee considerations

    The evidence

    3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 4 sources, which was discussed by the committee. The evidence included 1 systematic review and 3 randomised controlled trials (2 of which were also included in the systematic review). It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

    3.2 The professional experts and the committee considered the key efficacy outcomes to be:

    • outcomes for the woman – reduced time from uterine incision to birth, extension of uterine incision, blood loss, and operative complications

    • outcomes for the baby – improved Apgar scores and umbilical artery pH; reduced sepsis, need for admission to a special care baby unit or newborn intensive care unit, need for intubation, and death.

    3.3 The professional experts and the committee considered the key safety outcomes to be: infection, trauma to the vagina or baby's head.

    3.4 Patient commentary was sought but none was received.

    Committee comments

    3.5 It would be helpful to collect outcomes for the woman and baby after this procedure as part of a national audit.

    3.6 The committee was informed that there is a requirement for training in this procedure and noted this is provided by the manufacturer.

    3.7 The committee did not note any major safety concerns with this procedure.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    June 2022

    ISBN: